The Weakest Link: Poor quality therapists a risk to psychedelic trial success
This article was written in collaboration with Dr Sarah Bateup.
The ‘War on Drugs’ declared by Richard Nixon in the 1960s is often credited with the downfall of psychedelic research. Despite being influential, Nixon’s policies were not the only cause of psychedelic drugs’ demise. Other drugs such as morphine and amphetamines kept their dual lives as illegal street drugs and valuable tools of medicine while psychedelics experienced issues trying to deliver well-controlled trials to prove their efficacy. This ultimately led to the pharmaceutical industry's lack of interest in funding further trials.
Pharmaceutical research faced heightened objectivity and standardisation due to tighter regulation after the Thalidomide disaster in 1963. Thalidomide, which was not tested vigorously enough at the time, was prescribed as an anti-sickness pill for pregnant women in 49 countries until its side effects on the development of limbs and internal organs of fetuses were discovered.
Following the acceptance of randomised double-blind controlled trials’ status as the gold standard in efficacy testing, psychiatry separated into two arms: the pharmaceutical arm, which included “magic bullet” type drugs, and the psychological arm, which was of little interest to regulators. The complex interaction between the two exposed psychedelic trials to criticism on trial design and proof of efficacy. This led to sub-optimal results and the abandonment of psychedelic research.
Today, psychedelic trials face the same challenges. In psychedelic-assisted therapy, two ‘treatments’ are essentially delivered to the patient at the same time: the drug and the therapy. This leads to two variables that need dissecting to understand the efficacy and effectiveness of psychedelic-assisted therapy, and makes standardisation difficult to achieve. It is crucial that therapy is consistently delivered to a high standard, with fidelity to the model and that the quality of the therapy can be monitored and measured.
Delivering effective therapy in clinical trials requires quality therapists. However, it's widely reported that a third of therapists have very low levels of competency. Clerkenwell Health’s Head of Therapy, Dr Sarah Bateup, produced her doctorate in therapist variables to understand why this is the case and her research unearthed some interesting findings.
Dr Sarah Bateup at Clerkenwell Health’s clinical trial unit.
Why are some therapists better than others?
Although a significant variance existed between therapists, Sarah found that there is no relationship between high academic achievement or years of experience and good clinical outcomes. Instead, the way therapists are recruited, trained, assessed and monitored was the issue.
Evidence shows that having certain personality traits, such as being empathic and reflective, is a better predictor for becoming an effective therapist, yet as things stand therapists are usually selected for training courses purely based on their qualifications and experience.
“We wouldn’t let a surgeon perform a full surgery without having first observed a lot of their clinical practice”
Furthermore, training methods have improved little over the years despite their shortcomings, and not much attention has been paid to the assessment of training outcomes. We wouldn’t let a surgeon perform a full surgery without first observing a lot of their clinical practice. We would not let them perform a full surgery after only reading essays they had written.
Despite this, under the UK’s system, we let therapists deliver full treatments to vulnerable patients once they can write a good essay – meaning therapists can attend clinical practice without observation from a superior.
While a therapist’s knowledge is assessed following training, their ability to apply this knowledge in clinical practice isn’t properly evaluated. Even if they are not fit for the job, hardly anyone fails therapy training. When these therapists become qualified to work, their adherence to the therapy model and competence in delivering it is not monitored either. They receive very little feedback to improve their clinical practice throughout their careers. It all points to a system in need of reform.
What does this mean for psychedelic trials?
People who participate in psychedelic trials are for the most part, significantly unwell and they are administered drugs that make them even more vulnerable. It’s imperative that the industry abides by the highest standards not only for the drugs we administer, but also for the therapy we deliver. In psychedelic-assisted therapy trials around the world, therapist variance is already a huge problem. Ensuring the consistency of therapy across individuals and sites is difficult, which in turn skews trial results.
The extent of poor therapy practice is magnified in psychedelic trials. We hypothesise that when an evidence-based therapy is delivered consistently, it will improve the response rates of participants, increase the durability of treatments and reduce the likelihood of serious adverse events.
Not having robust ways of assessing the adherence and fidelity of therapists to the therapy model and their competence in delivering it also slows down scientific progress. Without knowing what therapists are doing in the room and how well they are doing it, we cannot identify what treatment model works best for which patient population.
Demonstrating the efficacy of psychedelic-assisted therapy over existing treatments is essential for the approval of psychedelic drugs. Having a clear understanding of therapy variables in clinical trials will also lead to clear results. A robust assessment of these variables in clinical trials will make it easier to compare the effectiveness of drugs, therapy models and courses of treatment.
How Clerkenwell Health train therapists and deliver therapy
Based on Dr Bateup’s research on the variables that make a great therapist, we have developed the most vigorous therapist selection and assessment criteria in the market and designed an evidence-based training programme.
In our therapist training programme, we teach practical skills as well as theory and consistently monitor our trainees' practice in order to provide feedback for continuous improvement. Our practical examination ensures that only the therapists who can deliver therapy consistently to a high standard will participate in our clinical trials. Since our therapists are trained with a transdiagnostic therapy model, upskilling them for each new trial is quick and easy.
We have also developed an AI-backed robust monitoring process to assess our therapists’ fidelity to therapy manuals and provide ongoing evidence-based support. This is how we ensure the quality of therapy, the safety of participants and the consistency across individuals and sites in clinical trials.
If we want to avoid the second fall of psychedelic research, we need to learn from the history of science. Although double-blind controlled trials were not designed to test the efficacy of drug-assisted psychotherapies, we can now standardise and control for therapy with the help of technology and evidence-based therapy models.
